Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-12 @ 12:02 PM
Study NCT ID:
NCT03679494
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm437106006@tmu.edu.tw', 'phone': '+886-2-27361661', 'title': 'MS. Po-Yao Chiu', 'phoneExt': '6311', 'organization': 'Taipei MU'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks', 'description': 'This is a questionnaire interview study, if patients are tired or feel unwell due to the long questionnaire, they can stop the visit at any time and immediately contact the relevant medical unit.', 'eventGroups': [{'id': 'EG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Change of Patients' Control Preference", 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}], 'classes': [{'title': 'Before intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Make final selection I will receive', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': "Make selection with doctor's opinion", 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Make selection with doctor', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Make selection by doctor', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Up to 12 weeks after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Make final selection I will receive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': "Make selection with doctor's opinion", 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Make selection with doctor', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Make selection by doctor', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Before intervention, up to 12 weeks after intervention', 'description': "Use Control Preference Scale to measure the patients' preferred role whether change in making decisions with the medical provider before intervention and after intervention. It consists of five cards, each of which presents a different character in medical decision-making in a cartoon pattern, and performs a series of comparisons to rank the preference.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients lost after 12 weeks of intervention.'}, {'type': 'PRIMARY', 'title': "The Change of Patients' Decision Self-efficacy", 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}], 'classes': [{'title': 'Before intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.78', 'spread': '16.78', 'groupId': 'OG000'}, {'value': '79.51', 'spread': '19.31', 'groupId': 'OG001'}]}]}, {'title': 'After intervention immediately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.57', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '81.27', 'spread': '18.96', 'groupId': 'OG001'}]}]}, {'title': 'Up to 12 weeks after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.01', 'spread': '18.61', 'groupId': 'OG000'}, {'value': '85.39', 'spread': '16.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before intervention, after intervention immediately, up to 12 weeks after intervention', 'description': "Use Decision Self Efficacy Scale to measure patients' self-confidence and belief in measuring the ability of patients to participate in decision-making. It has 11 items with 5 level Likert scale. The scale range is 0-100, higher scores indicate better decision self-efficacy.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients lost after the intervention immediately and up to 12 weeks after intervention.'}, {'type': 'SECONDARY', 'title': 'Assess Decision Process Quality in Making the Decision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '87.47', 'spread': '12.30', 'groupId': 'OG000'}, {'value': '81.76', 'spread': '19.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After intervention immediately', 'description': 'Assess whether the medical personnel have sufficiently communicated with patients when making the decision by 9-item Shared Decision Making Questionnaire(SDM-Q-9). It has 9 items and is divided into 0 to 5 scores, 0 points = very disagree, 1 point = roughly disagree, 2 points = partial disagreement, 3 points = partial consent, 4 points = roughly agree, 5 points = very agree. After the total score of each question is added, the initial total score is 0 to 45 points. Divide the initial total score by 9 and multiply by 20 to get the final score from 0 to 100. The higher the score means the better the decision-sharing on behalf of the patient.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Assess Patients' Satisfaction With Decision", 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}], 'classes': [{'title': 'After intervention immediately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.29', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '25.06', 'spread': '4.60', 'groupId': 'OG001'}]}]}, {'title': 'Up to 12 weeks after the intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.02', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '25.44', 'spread': '4.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After intervention immediately, up to 12 weeks after the intervention', 'description': 'Use Satisfaction with Decision Scale to assess patients satisfaction with health care decisions. It has 6 items with 5 level Likert scale. 1 point = very disagree, 2 points = disagree, 3 points = disagree or disagree, 4 points = agree, 5 points = very agree. After the total score of each question is added, the initial total score is 6 to 30 points. The higher the score, patients are more satisfied with the decision.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The patients lost up to 12 weeks after the intervention.'}, {'type': 'SECONDARY', 'title': "Assess Patients' Decisional Conflict", 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}], 'classes': [{'title': 'After intervention immediately', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.30', 'spread': '10.46', 'groupId': 'OG000'}, {'value': '18.25', 'spread': '18.44', 'groupId': 'OG001'}]}]}, {'title': 'Up to 12 weeks after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.77', 'spread': '17.56', 'groupId': 'OG000'}, {'value': '15.27', 'spread': '14.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After intervention immediately and up to 12 weeks after intervention', 'description': 'Use the Decisional Conflict Scale to assess patients whether have a conflict or something not sure about making the decision. It has 16 items with 5 levels Likert scale. 0 points = yes, 1 point = about yes, 2 points = uncertainty, 3 points = probably not, 4 points = no. After the total score of each question is added, the initial total score is 0 to 64 points. Divide the initial total score by 16 and multiply by 25 to get the final score from 0 to 100. The higher the score, patients have more conflict with the decision.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients lost after up to 12 weeks after intervention.'}, {'type': 'SECONDARY', 'title': 'Assess the Degree of Disability of Lower Back Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}], 'classes': [{'title': 'Before intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.38', 'spread': '15.67', 'groupId': 'OG000'}, {'value': '24.62', 'spread': '12.90', 'groupId': 'OG001'}]}]}, {'title': 'Up to 12 weeks after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.22', 'spread': '31.06', 'groupId': 'OG000'}, {'value': '21.12', 'spread': '25.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before intervention, up to 12 weeks after intervention', 'description': "Use the Oswestry Disability Index to measure lower back pain patients' degree of disability. It has 10 items (Pain, self-care, bring, walking, sitting, standing, sleeping, sex, social, travelling). After adding up the total score of each item, the initial total score is 0 to 50 points. Then divide the total score by 5 and multiply by 20 to get the final score of 0 to 100. Higher scores indicate a more severe disability.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients lost up to 12 weeks after intervention.'}, {'type': 'SECONDARY', 'title': 'Assess the Quality of Healthy Living About Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}], 'classes': [{'title': 'Before intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Up to 12 weeks after intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before intervention, up to 12 weeks after intervention', 'description': "Use the EQ-5D-5L scale to measure patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients lost up to 12 weeks after intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'FG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SDM Intervention Group', 'description': 'Using shared decision making support tool for intervention\n\nShared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions'}, {'id': 'BG001', 'title': 'Usual Care Group', 'description': 'No intervention, just continue using usual care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.46', 'spread': '14.853', 'groupId': 'BG000'}, {'value': '55.78', 'spread': '15.315', 'groupId': 'BG001'}, {'value': '56.13', 'spread': '15.024', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-25', 'size': 322721, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-29T09:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2018-09-06', 'resultsFirstSubmitDate': '2019-12-30', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-18', 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Change of Patients' Control Preference", 'timeFrame': 'Before intervention, up to 12 weeks after intervention', 'description': "Use Control Preference Scale to measure the patients' preferred role whether change in making decisions with the medical provider before intervention and after intervention. It consists of five cards, each of which presents a different character in medical decision-making in a cartoon pattern, and performs a series of comparisons to rank the preference."}, {'measure': "The Change of Patients' Decision Self-efficacy", 'timeFrame': 'Before intervention, after intervention immediately, up to 12 weeks after intervention', 'description': "Use Decision Self Efficacy Scale to measure patients' self-confidence and belief in measuring the ability of patients to participate in decision-making. It has 11 items with 5 level Likert scale. The scale range is 0-100, higher scores indicate better decision self-efficacy."}], 'secondaryOutcomes': [{'measure': 'Assess Decision Process Quality in Making the Decision', 'timeFrame': 'After intervention immediately', 'description': 'Assess whether the medical personnel have sufficiently communicated with patients when making the decision by 9-item Shared Decision Making Questionnaire(SDM-Q-9). It has 9 items and is divided into 0 to 5 scores, 0 points = very disagree, 1 point = roughly disagree, 2 points = partial disagreement, 3 points = partial consent, 4 points = roughly agree, 5 points = very agree. After the total score of each question is added, the initial total score is 0 to 45 points. Divide the initial total score by 9 and multiply by 20 to get the final score from 0 to 100. The higher the score means the better the decision-sharing on behalf of the patient.'}, {'measure': "Assess Patients' Satisfaction With Decision", 'timeFrame': 'After intervention immediately, up to 12 weeks after the intervention', 'description': 'Use Satisfaction with Decision Scale to assess patients satisfaction with health care decisions. It has 6 items with 5 level Likert scale. 1 point = very disagree, 2 points = disagree, 3 points = disagree or disagree, 4 points = agree, 5 points = very agree. After the total score of each question is added, the initial total score is 6 to 30 points. The higher the score, patients are more satisfied with the decision.'}, {'measure': "Assess Patients' Decisional Conflict", 'timeFrame': 'After intervention immediately and up to 12 weeks after intervention', 'description': 'Use the Decisional Conflict Scale to assess patients whether have a conflict or something not sure about making the decision. It has 16 items with 5 levels Likert scale. 0 points = yes, 1 point = about yes, 2 points = uncertainty, 3 points = probably not, 4 points = no. After the total score of each question is added, the initial total score is 0 to 64 points. Divide the initial total score by 16 and multiply by 25 to get the final score from 0 to 100. The higher the score, patients have more conflict with the decision.'}, {'measure': 'Assess the Degree of Disability of Lower Back Pain', 'timeFrame': 'Before intervention, up to 12 weeks after intervention', 'description': "Use the Oswestry Disability Index to measure lower back pain patients' degree of disability. It has 10 items (Pain, self-care, bring, walking, sitting, standing, sleeping, sex, social, travelling). After adding up the total score of each item, the initial total score is 0 to 50 points. Then divide the total score by 5 and multiply by 20 to get the final score of 0 to 100. Higher scores indicate a more severe disability."}, {'measure': 'Assess the Quality of Healthy Living About Patients', 'timeFrame': 'Before intervention, up to 12 weeks after intervention', 'description': "Use the EQ-5D-5L scale to measure patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Degenerative Disease', 'Shared Decision Making', 'Patient Decision Aids', 'Evidence-based Medicine', 'Quality of Care']}, 'descriptionModule': {'briefSummary': "Background:\n\nShared decision making (SDM) is a patient-centered and evidence-based model of clinical decision making. The feature of SDM is that clinicians work together with patients to plan the most appropriate and practical treatment for patients based on the patients' preferences and values. Recently, SDM has been implemented throughout the world to improve patients' health literacy and to have a better understanding of the treatment options, thereby improving patient-doctor communication and promoting the quality of care.\n\nLumbar degenerative disease is a critical public health issue in the aging society. SDM now becomes an important process because there is no consensus of evidence-based practice guidelines among the multiple complex treatment options for patients with lumbar degenerative disease. In addition, there is a lack of evidence to support the effect of patient decision aids (PDAs) to promote the quality of healthcare for patients with lumbar degenerative disease in Taiwan.\n\nPurposes:\n\nThis project has two purposes. The first purpose is to develop a multimedia interactive patient doctor communication system called the Taiwan Shared Decision Making for Lumbar Spine Treatment (Taiwan SDM LumST). The second and ultimate purpose is to conduct a cluster randomized controlled trial (cRCT) for the validation of the integrated SDM model and the effectiveness of SDM related outcome indicators.\n\nMethods:\n\nIn the first year of the 3-year project, investigators will develop the SDM communication teaching materials, PDAs, as well as the computerized platform of Taiwan SDM LumST through focus groups and consensus meetings. In the second to third year, investigators will recruit 130 patients with lumbar degenerative disease to participate in double blind cRCT in the affiliated hospitals of Taipei Medical University. Investigators will use structural equation modeling to validate the factors of the SDM model and adopt generalized linear regression models with generalized estimating equations to examine the immediate, short-term, and long-term benefits of the Taiwan SDM LumST in implementing the SDM model among patients with lumbar degenerative disease.\n\nExpected results:\n\nInvestigators expect that the implementation of the Taiwan SDM LumST system will significantly improve the patients' decision preference, health literacy in the care of lumbar degenerative disease, and self-efficacy in SDM. It will also promote the health care quality and health outcomes (e.g., participation in SDM, quality of decisions, regret in decisions, health outcomes, and quality-of-life) in patients with lumbar degenerative disease.\n\nExpected impacts on the society, economy, and academic developments:\n\nThe Taiwan SDM LumST will be an efficient and effective way to facilitate patient doctor communication and thereby, promote health outcomes and improve the quality of decisions made by patients with lumbar degenerative disease. No computerized interactive PDA of SDM system for patients with lumbar degenerative disease exists in Taiwan yet. Thus, our system would be the first in Taiwan for the lumbar degenerative population. Investigators hope that the Taiwan SDM LumST will not only contribute to academic research, but also facilitate SDM between patients and healthcare professionals in order to improve patient safety and enhance the quality of care in Taiwan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-time diagnosis of Spine Degeneration Diseases ICD-10 codes M48.05-08, M43.05-08, M43.15-18, M54.5; ICD-9 codes 724.01-02、724.09、724.2、738.4\n* Ability to follow instructions and complete the interviews\n* Age\\>20 years\n* Interested to participate and able to sign consent\n\nExclusion Criteria:\n\n* Cognitive impairment (Mini-Mental State Examination scores\\<24)\n* Having major mental diseases (i.e., depression, dementia, delirium, etc.)\n* Inability to read/answer questionnaires'}, 'identificationModule': {'nctId': 'NCT03679494', 'briefTitle': 'Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases.', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail', 'orgStudyIdInfo': {'id': 'N201712035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SDM intervention group', 'description': 'Using shared decision making support tool for intervention', 'interventionNames': ['Other: Shared decision making support tool']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care group', 'description': 'No intervention, just continue using usual care'}], 'interventions': [{'name': 'Shared decision making support tool', 'type': 'OTHER', 'description': 'Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions', 'armGroupLabels': ['SDM intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}